During this Live Online Training, the following contents and questions should be addressed by presentations and panel discussions. Considering that, panelists from the fields Non-Sterile Products, Sterile Products, Combination Products as well as biopharmaceutical APIs and HCT/Ps will on hand for the training.
Background
In their Pharmacopeial Forum 39(4) in 2014, the USP published the draft of chapter <1115> “Bioburden Control of Nonsterile Drug Substances and Products”. The document outlines a risk-based approach to the control of potential contamination in non-sterile product manufacturing.
But “bioburden” is not only a topic of non-sterile products. Annex 1 of the European GMP Guideline requires “The bioburden should be monitored before sterilisation. There should be working limits on contamination immediately before sterilisation, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilised products.”
And last but not least, bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737.
The current developments determine us to address this topic in a special workshop session to look at this from various angles and provide you with information about the regulatory background and practical examples and strategies for bioburden control. Pharmacopoeial experts, representatives of pharmaceutical quality control and from testing laboratory will show you what are the challenges of the bioburden control strategy and how they implemented an adequate control in their companies.
Target Group
This Live Online Training is of interest to professionals in microbiology from
Pharmaceuticals and Biopharmaceutical Companies
Academic Research Institutions
Government Agencies
Contract Service laboratories
who are involved in
Research and Development
Validation
Microbiological QA and QC
Technical Requirements
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Bioburden control strategy dependent of the lifecycle phase of the product (so-called “Phase-appropriate control strategy”) - Early clinical Phase - Late clinical hase - Commercial phase
Test for “specified microorganisms” and / or “objectionable microorganisms”? - Raw materials - In-process-control samples - Drug substance - Drug product - Final product
Refresher on biofilms including case studies - Biofilm biology - How to recognize biofilms in bioburden Trends - Lessons learned from a company
Testing
Where is bioburden tested in processes?
Predefinition of bioburden and / or endotoxins levels for raw materials
Assessment of the presence / absence of “objectionable microorganisms” in your raw materials ?
What are the methods in use ? - TAMC - TYMC - MPN - Any other bioburden testing method - Rapid micro methods
Is it necessary to have a limited shelf life for bioburden samples?
How to treat so called “missing bioburden” results ?
Limits
Predefined bioburden and / or endotoxins levels for your upstream / fermentation processes (if applicable) and downstream processes or for the whole process
What will be preferred? A two-tiered-control system (warning and alert level) or a three-tiered control system (warning and alert level AND rejection level)?
Methodologies in use to define the limits, e.g.
how many data points are required to define the limits
philosophy for new processes / new manufacturing processes without having experience of process capabilities
Deviation Management
Do you perform ID? If YES, when: - Each Colony - Only in case of an excursion of limits / level
What’s the preferred ID technique?
Measures in case of an excursion of a Limit
USP <1115>, USP<1229.3> and USP <1119>
Bioburden control of non-sterile drug substances and products – USP and industrial view
Bioburden monitoring, USP<1229.3> applies to sterile products
USP <1119>
Presentation list:
European Regulations
USP<1115> Bioburden Control of Non-Sterile Drug Substances and Products
Refresher on biofilms including case studies
Microbial Control Strategy for Biopharmaceutical Manufacturing
Microbial Counts and Bioburden of Combination Products: Guidelines, Specifics and Case Studies
Bioburden for Sterile Operations
Bioburden Monitoring, USP<1229.3> applies to Sterile Products, USP <1119>
Bioburden Testing of Modern Medicinal Products- Practical Experience of a Contract Lab - Various types of bioburden testing - Technical challenges: Non-Steriles up to ATMP - Practical Examples - from classic Pharmaceutical Products to HCT/Ps
Minimizing the impact of bioburden and sterility testing on gene therapy batch yield
Assessment of Bioburden Excursions in Non-Sterile Biologics Manufacturing Processes
This course is part of the GMP Certification Programme "ECA Certified Microbiological Laboratory Manager" Learn more
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Seminar Programme as PDF